Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanxi Province Cancer Hospital
About this trial
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient voluntarily participated in this study and signed an informed consent form；
All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's sarcoma/primary neuroectodermal tumor, connective tissue proliferative small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma, chondrosarcoma, osteosarcoma. Except for the following types: malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma;
Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment;
18~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
Disqualifiers
Patients who have previously used sildenafil or other histone deacetylase inhibitors;
Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);
Other malignant tumors that have occurred or are currently present within the past 5 years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)];
Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment;
Trial design
Design model
Sequential
Treatments tested in this trial
Chidamide Tablets combined with AK112
DrugChidamide Tablets 30mg/day, po.Bid; AK112（10mg/kg or 20mg/kg）, ivgtt, Q3W.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Chidamide Tablets combined with AK112Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The efficacy of the investigational drug will be determined by the objective tumor evaluation conducted by the research center based on the RECIL 2017 lymphoma efficacy evaluation criteria
The imaging evaluation methods for tumors are PET/CT, MR, or CT, but the evaluation methods, machines, and technical parameters should be consistent throughout the entire study period. The imaging results are interpreted by researchers or radiologists from each research center. If tumor evaluation has been conducted within 21 days before enrollment and the same methods and machines are used in the same hospital, it can be used as a baseline tumor evaluation. Baseline tumor evaluation should include the nasal cavity, chest, abdomen, pelvic cavity, and any other suspected tumor lesions. If there are clinical indications, appropriate methods can be used to examine any other known or suspected disease site, such as cranial MRI or bone scan.
Time frame
Baseline and testing every 6 weeksSponsors and contacts
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Source ClinicalTrials.gov